Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
研究概览
简要总结
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
排除标准
- 未提供
研究组 & 干预措施
A
干预措施: Atazanavir+Ritonavir+Tenofovir (Drug)
B
干预措施: Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug)
C
干预措施: Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug)
D
干预措施: Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug)
E
干预措施: Atazanavir+Ritonavir+Tenofovir+Famotidine (Drug)
结局指标
主要结局
Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
次要结局
- Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.